Study to Evaluate the Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Positive, Antiretroviral Treatment-Naive Adults



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/21/2018
Start Date:December 26, 2012
End Date:September 6, 2017

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A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults

The primary objective of this study is to evaluate the efficacy of
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose
combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
(E/C/F/TDF) FDC in HIV-1 positive, antiretroviral treatment-naive adults.


Key Inclusion Criteria:

- Ability to understand and sign a written informed consent form, which must be obtained
prior to initiation of study procedures

- Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening

- No prior use of any approved or investigational antiretroviral drug for any length of
time, except the use for pre-exposure prophylaxis (PREP) or post-exposure prophylaxis
(PEP), up to 6 months prior to screening

- Screening genotype report must show sensitivity to elvitegravir, emtricitabine,
tenofovir disoproxil fumarate (tenofovir DF)

- Normal electrocardiogram (ECG)

- Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the
Cockcroft-Gault formula for creatinine clearance

- Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin

- Adequate hematologic function

- Serum amylase ≤ 5 × ULN

- Males and females of childbearing potential must agree to utilize highly effective
contraception methods or be non-heterosexually active or practice sexual abstinence
from screening throughout the duration of study treatment and for 30 days following
the last dose of study drug

- Females who utilize hormonal contraceptive as one of their birth control methods must
have used the same method for at least three months prior to study dosing

- Females who have stopped menstruating for ≥ 12 months but do not have documentation of
ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at
screening within the post-menopausal range based on the Central Laboratory reference
range

Key Exclusion Criteria:

- A new acquired immunodeficiency syndrome (AIDS) defining condition diagnosed within
the 30 days prior to screening

- Hepatitis B surface antigen (HBsAg) positive

- Hepatitis C antibody positive

- Individuals experiencing decompensated cirrhosis

- Females who are breastfeeding

- Positive serum pregnancy test

- Have an implanted defibrillator or pacemaker

- Current alcohol or substance use judged by the Investigator to potentially interfere
with study compliance

- History of malignancy within the past 5 years or ongoing malignancy other than
cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous
squamous carcinoma

- Active, serious infections (other than HIV-1 infection) requiring parenteral
antibiotic or antifungal therapy within 30 days prior to baseline

- Any other clinical condition or prior therapy that, in the opinion of the
Investigator, would make the individual unsuitable for the study or unable to comply
with dosing requirements

- Participation in any other clinical trial (including observational trials) without
prior approval

- Individuals receiving ongoing therapy with drugs not to be used with elvitegravir,
cobicistat, emtricitabine, tenofovir DF, and TAF or individuals with any known
allergies to the excipients of E/C/F/TDF or E/C/F/TAF single-tablet regimen tablets

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
79
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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900 East 30th Street
Austin, Texas 78705
512-480-9660
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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4025 North Sheridan Road
Chicago, Illinois 60613
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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707 Hollybrook Drive
Longview, Texas 75605
903-238-8854
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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Akron, Ohio 44304
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
Albany Medical College Albany Medical Center is northeastern New York's only academic health sciences center...
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Atlanta, Georgia 30308
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Atlanta, Georgia 30309
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Bellaire, Texas 77401
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Berkley, Michigan 48072
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Boston, Massachusetts 02111
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1400 Pelham Parkway South
Bronx, New York 10461
(718) 918-5000
Jacobi Medical Center In 1955, the NYC Department of Hospitals opened a new, specialized care...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28209
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Chicago, Illinois 60612
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303 East Superior Street
Chicago, Illinois 60611
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Columbia, South Carolina 29203
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Darlinghurst, New South Wales
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Denver, Colorado 80209
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Flushing, New York 11355
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Fort Lauderdale, Florida 33316
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Fort Pierce, Florida 34982
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Framingham, Massachusetts 01702
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Harlingen, Texas 78550
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Hillsborough, New Jersey 08844
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Houston, Texas 77098
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Houston, Texas 77004
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Huntersville, North Carolina 28078
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Los Angeles, California 90036
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Miami, Florida 33133
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Miami Beach, Florida 33139
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Minneapolis, Minnesota 55414
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New York, New York 10029
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Newark, New Jersey 07102
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Oakland, California 94609
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Orlando, Florida 32806
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1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Pensacola, Florida 32504
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Phoenix, Arizona 85012
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164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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6600 Bruceville Road
Sacramento, California 95823
(916) 688-2000
Kaiser Permanente - Sacramento At the Kaiser Permanente South Sacramento Medical Center, you and your...
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Saint Louis, Missouri 63108
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Saint Louis, Missouri 63139
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San Diego, California 92103
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San Diego, California 92093
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Santa Fe, New Mexico 87505
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Seattle, Washington 98104
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Springfield, Massachusetts 01199
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Washington, District of Columbia 20009
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Washington, District of Columbia 20036
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